RU2011114292A - COMPOSITE POWDER OF ORGANIC SUBSTANCE FOR USE IN MEDICINE, METHOD OF ITS PRODUCTION AND ITS SUSPENSION - Google Patents

COMPOSITE POWDER OF ORGANIC SUBSTANCE FOR USE IN MEDICINE, METHOD OF ITS PRODUCTION AND ITS SUSPENSION Download PDF

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RU2011114292A
RU2011114292A RU2011114292/15A RU2011114292A RU2011114292A RU 2011114292 A RU2011114292 A RU 2011114292A RU 2011114292/15 A RU2011114292/15 A RU 2011114292/15A RU 2011114292 A RU2011114292 A RU 2011114292A RU 2011114292 A RU2011114292 A RU 2011114292A
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composite powder
composite
organic substance
sodium
indomethacin
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RU2011114292/15A
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RU2535017C2 (en
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Такаси ХИРОКАВА (JP)
Такаси ХИРОКАВА
Такахиро ТАДА (JP)
Такахиро ТАДА
Юн НИХИРА (JP)
Юн НИХИРА
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Активус Фарма Ко., Лтд. (Jp)
Активус Фарма Ко., Лтд.
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/222—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin with compounds having aromatic groups, e.g. dipivefrine, ibopamine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4174—Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Abstract

1. Композитный порошок из органического вещества для применения в медицине, включающий композитные частицы, в которых лецитин нанесен на поверхность частиц плохо растворимого в воде органического вещества, или композитные частицы, в которых органическое вещество и лецитин образуют композит на наноуровне, имеющий средний диаметр частиц, равный 400 нм или менее, как рассчитано в объемном выражении. ! 2. Композитный порошок по п.1, в котором органическое вещество представляет собой, одно или несколько соединений, которые выбирают из группы, состоящей из фенофибрата, фелбинака, пранлукаста гидрата, миконазола, флутиказона пропионата, индометацина, амфотерицина В, ацикловира, нифедипина, никардипина, нимодипина, дипиридамола, дизопирамида, празозина гидрохлорида, преднизолона, кортизона ацетата, дексаметазона, бетаметазона, беклометазона дипропионата, будесонида, флуцинолона ацетонида, напроксена, кетопрофена, 7-(3,5-диметокси-4-гидроксициннамоиламино)-3-октилокси-4-гидрокси-1-метил-2(1Н)-хинолинона, фенитоина, фенацетамида, этотоина, примидона, диазепама, нитразепама, клоназепама, дигитоксина, спиронолактона, триамтерена, хлорталидона, политиазида, бензтиазида, гризеофульвина, налидиксовой кислоты, хлорамфаникола, хлорзоксазина, фенпробамата, мехитазина, бисбентиамина, митомицина С, бикалутамида, паслитакселя, убенимекса, дакарбазина, флуконазола, рифампицина, триамцинолона ацетонида, клемастина фумарата, зафирлукаста, дигидрохолестерола, β-каротин, пропилгаллата, коричной кислоты, сахарина, фолевой кислоты и мальтола. ! 3. Композитный порошок по п.2, который представляет собой порошок, по меньшей мере, из любого из: 1. A composite powder of an organic substance for use in medicine, comprising composite particles in which lecithin is applied to the surface of particles of poorly water-soluble organic matter, or composite particles in which organic matter and lecithin form a composite at a nanoscale having an average particle diameter, equal to 400 nm or less, as calculated in volume terms. ! 2. The composite powder according to claim 1, in which the organic substance is one or more compounds that are selected from the group consisting of fenofibrate, felbinac, pranlucast hydrate, miconazole, fluticasone propionate, indomethacin, amphotericin B, acyclovir, nifedipine, nicardipine , nimodipine, dipyridamole, disopyramide, prazosin hydrochloride, prednisone, cortisone acetate, dexamethasone, betamethasone, beclomethasone dipropionate, budesonide, flucinolone acetonide, naproxen, ketoprofen, 7- (3,5-dimethoxy-4-hydroxy nnamoylamino) -3-octyloxy-4-hydroxy-1-methyl-2 (1H) -quinolinone, phenytoin, phenacetamide, ethotoin, primidone, diazepam, nitrazepam, clonazepam, digitoxin, spironolactone, triamterene, chlortalidazide, benz nalidixic acid, chloramphenicol, chlorzoxazazine, fenprobamate, mechitazine, bisbentiamine, mitomycin C, bicalutamide, paslitaxel, ubenimex, dacarbazine, fluconazole, rifampicin, triamcinolone acetonide, clemastarate-cafferolate, zafirolol zafirolol acid, saccharin, folic acid, and maltol. ! 3. The composite powder according to claim 2, which is a powder of at least any of:

Claims (14)

1. Композитный порошок из органического вещества для применения в медицине, включающий композитные частицы, в которых лецитин нанесен на поверхность частиц плохо растворимого в воде органического вещества, или композитные частицы, в которых органическое вещество и лецитин образуют композит на наноуровне, имеющий средний диаметр частиц, равный 400 нм или менее, как рассчитано в объемном выражении.1. A composite powder of an organic substance for use in medicine, comprising composite particles in which lecithin is applied to the surface of particles of poorly water-soluble organic matter, or composite particles in which organic matter and lecithin form a composite at a nanoscale having an average particle diameter, equal to 400 nm or less, as calculated in volume terms. 2. Композитный порошок по п.1, в котором органическое вещество представляет собой, одно или несколько соединений, которые выбирают из группы, состоящей из фенофибрата, фелбинака, пранлукаста гидрата, миконазола, флутиказона пропионата, индометацина, амфотерицина В, ацикловира, нифедипина, никардипина, нимодипина, дипиридамола, дизопирамида, празозина гидрохлорида, преднизолона, кортизона ацетата, дексаметазона, бетаметазона, беклометазона дипропионата, будесонида, флуцинолона ацетонида, напроксена, кетопрофена, 7-(3,5-диметокси-4-гидроксициннамоиламино)-3-октилокси-4-гидрокси-1-метил-2(1Н)-хинолинона, фенитоина, фенацетамида, этотоина, примидона, диазепама, нитразепама, клоназепама, дигитоксина, спиронолактона, триамтерена, хлорталидона, политиазида, бензтиазида, гризеофульвина, налидиксовой кислоты, хлорамфаникола, хлорзоксазина, фенпробамата, мехитазина, бисбентиамина, митомицина С, бикалутамида, паслитакселя, убенимекса, дакарбазина, флуконазола, рифампицина, триамцинолона ацетонида, клемастина фумарата, зафирлукаста, дигидрохолестерола, β-каротин, пропилгаллата, коричной кислоты, сахарина, фолевой кислоты и мальтола.2. The composite powder according to claim 1, in which the organic substance is one or more compounds that are selected from the group consisting of fenofibrate, felbinac, pranlucast hydrate, miconazole, fluticasone propionate, indomethacin, amphotericin B, acyclovir, nifedipine, nicardipine , nimodipine, dipyridamole, disopyramide, prazosin hydrochloride, prednisone, cortisone acetate, dexamethasone, betamethasone, beclomethasone dipropionate, budesonide, flucinolone acetonide, naproxen, ketoprofen, 7- (3,5-dimethoxy-4-hydroxy nnamoylamino) -3-octyloxy-4-hydroxy-1-methyl-2 (1H) -quinolinone, phenytoin, phenacetamide, ethotoin, primidone, diazepam, nitrazepam, clonazepam, digitoxin, spironolactone, triamterene, chlortalidazide, benz nalidixic acid, chloramphenicol, chlorzoxazazine, fenprobamate, mechitazine, bisbentiamine, mitomycin C, bicalutamide, paslitaxel, ubenimex, dacarbazine, fluconazole, rifampicin, triamcinolone acetonide, clemastarate-cafferolate, zafirolol zafirolol acid, saccharin, folic acid, and maltol. 3. Композитный порошок по п.2, который представляет собой порошок, по меньшей мере, из любого из: амфотерицина В, ацикловира и индометацина, имеющий средний диаметр частиц, равный от 50 до 250 нм.3. The composite powder according to claim 2, which is a powder of at least one of amphotericin B, acyclovir and indomethacin having an average particle diameter of from 50 to 250 nm. 4. Суспензия, в которой диспергирован композитный порошок из органического вещества для применения в медицине по пп.1-3.4. A suspension in which a composite powder of organic matter is dispersed for use in medicine according to claims 1-3. 5. Композитный порошок по п.1 или п.2, который имеет дополнительно карбоксивиниловый полимер на поверхности лецитина или частиц органического вещества.5. The composite powder according to claim 1 or claim 2, which further has a carboxyvinyl polymer on the surface of lecithin or particles of organic matter. 6. Композитный порошок по п.5, в котором органическое вещество представляет собой одно или несколько из соединений, которые выбирают из группы, состоящей из фенофибрата, фелбинака, пранлукаста гидрата, миконазола, флутиказона пропионата и индометацина.6. The composite powder according to claim 5, in which the organic substance is one or more of the compounds that are selected from the group consisting of fenofibrate, felbinac, pranlucast hydrate, miconazole, fluticasone propionate and indomethacin. 7. Суспензия, в которой диспергирован композитный порошок из органических веществ по п.5 или 6.7. A suspension in which a composite powder of organic substances is dispersed according to claim 5 or 6. 8. Способ получения композитного порошка из органического вещества для применения в медицине, включающий:8. A method of obtaining a composite powder from organic matter for use in medicine, including: смешивание плохо растворимого в воде порошка из органического вещества, физиологически приемлемой соли и физиологически приемлемого полиола и тонкое измельчение порошка из органического вещества;mixing poorly water-soluble powder from an organic substance, a physiologically acceptable salt and a physiologically acceptable polyol, and finely grinding the powder from an organic substance; добавление лецитина в процессе и/или после тонкого порошкования; иthe addition of lecithin during and / or after fine powdering; and удаление, по меньшей мере, соли и полиола после тонкого порошкования.removal of at least salt and polyol after fine trituration. 9. Способ по п.8, в котором органическое вещество представляет собой одно или несколько из соединений, которые выбирают из группы, состоящей из фенофибрата, фелбинака, пранлукаста гидрата, миконазола, флутиказона пропионата, индометацина, амфотерицина В, ацикловира, нифедипина, никардипина, нимодипина, дипиридамола, дизопирамида, празозина гидрохлорида, преднизалона, кортизона ацетата, дексаметазона, бетаметазона, беклометазона дипропионата, будесонида, флуцинолона ацетонида, напроксена, кетопрофена, 7-(3,5-диметокси-4-гидроксициннамоиламино)-3-октилокси-4-гидрокси-1-метил-2(1Н)-хинолинона, фенитоина, фенацетамида, этотоина, примидона, диазепама, нитразепама, клоназепама, дигитоксина, спиронолактона, триамтерена, хлорталидона, политиазида, бензтиазида, гризеофульвина, налидиксовой кислоты, хлорамфаникола, хлорзоксазина, фенпробамата, мехитазина, бисбентиамина, митомицина С, бикалутамида, паслитакселя, убенимекса, дакарбазина, флуконазола, рифампицина, триамцинолона ацетонида, клемастина фумарата, зафирлукаста, дигидрохолестерола, β-каротина, пропилгаллата, коричной кислоты, сахарина, фолевой кислоты и мальтола.9. The method of claim 8, in which the organic substance is one or more of a compound selected from the group consisting of fenofibrate, felbinac, pranlucast hydrate, miconazole, fluticasone propionate, indomethacin, amphotericin B, acyclovir, nifedipine, nicardipine, nimodipine, dipyridamole, disopyramide, prazosin hydrochloride, prednisone, cortisone acetate, dexamethasone, betamethasone, beclomethasone dipropionate, budesonide, flucinolone acetonide, naproxen, ketoprofen, 7- (3,5-dimethoxy-4-hydroxycin o) -3-octyloxy-4-hydroxy-1-methyl-2 (1H) -quinolinone, phenytoin, phenacetamide, etotoin, primidone, diazepam, nitrazepam, clonazepam, digitoxin, spironolactone, triamterene, chlortalidone, polythiazide, benzithiazide nalidixic acid, chloramphenicol, chlorzoxazazine, fenprobamate, mechitazine, bisbentiamine, mitomycin C, bicalutamide, paslitaxel, ubenimex, dacarbazine, fluconazole, rifampicin, triamcinolone acetonide, clamastine fumarate, zaferolate, zafirol acid aharina, folic acid, and maltol. 10. Способ по п.8, в котором соль представляет собой одну или несколько из солей, которые выбирают из группы, состоящей из хлорида натрия, хлорида калия, хлорида аммония, сульфата натрия, сульфата магния, сульфата калия, сульфата кальция, малата натрия, цитрата натрия однозамещенного, цитрата натрия двузамещенного, дигидрогенцитрата натрия, дигидрогенцитрата калия, фосфорнокислого натрия однозамещенного, фосфорнокислого калия однозамещенного, фосфорнокислого натрия двузамещенного и фосфорнокислого калия двузамещенного.10. The method of claim 8, in which the salt is one or more of the salts that are selected from the group consisting of sodium chloride, potassium chloride, ammonium chloride, sodium sulfate, magnesium sulfate, potassium sulfate, calcium sulfate, sodium malate, monosubstituted sodium citrate, disubstituted sodium citrate, sodium dihydrogen citrate, potassium dihydrogen citrate, monosubstituted sodium phosphate, monosubstituted potassium phosphate, disubstituted sodium phosphate and disubstituted potassium phosphate. 11. Способ по пп.8-10, в котором полиол представляет собой глицерин, пропиленгликоль или полиэтиленгликоль.11. The method according to claims 8-10, wherein the polyol is glycerol, propylene glycol or polyethylene glycol. 12. Способ по пп.8-10, в котором соль представляет собой хлорид натрия и полиол представляет собой глицерин.12. The method according to claims 8-10, wherein the salt is sodium chloride and the polyol is glycerol. 13. Способ по любому из пп.8-10, дополнительно включающий стадию добавления карбоксивинилового полимера в процессе тонкого порошкования.13. The method according to any one of claims 8 to 10, further comprising the step of adding a carboxyvinyl polymer in the fine powder process. 14. Способ по п.13, в котором органическое вещество представляет собой одно или несколько из соединений, которые выбирают из группы, состоящей из фенофибрата, фелбинака, пранлукаста гидрата, миконазола, флутиказона пропионата и индометацина. 14. The method according to item 13, in which the organic substance is one or more of the compounds that are selected from the group consisting of fenofibrate, felbinac, pranlucast hydrate, miconazole, fluticasone propionate and indomethacin.
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